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Glecaprevir and Pibrentasvir for Chronic Kidney Disease (QUICK-CURE Trial)
QUICK-CURE Trial Summary
This trial studied the effects of pan-genotypic DAA therapy given to kidney transplant recipients to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney.
- Chronic Kidney Disease
- Hepatitis C
- Kidney Failure
QUICK-CURE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.QUICK-CURE Trial Design
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- Requirements for donors who have passed away.You have severe kidney disease (stage 5 CKD or ESRD) and have met the criteria for a kidney transplant at MGH Transplant Center.You have a positive test for the hepatitis C virus (HCV).You are able to fully understand the details of the study and are willing to sign a document stating that you agree to participate.Your kidney has a good score (KDPI score less than or equal to 0.850).You meet the standard criteria for organ donation.You do not have any serious liver conditions at the time of transplantation readiness as assessed by your clinical team.Requirements for being included in the study as a participant.Women must agree to use two forms of birth control, including a barrier method, when taking the study drug to prevent pregnancy.
- Group 1: Treatment with Direct Acting Antiviral for HCV
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the Glecaprevir and Pibrentasvir combination been granted sanction by the FDA?
"Based on the Phase 4 status of Glecaprevir and Pibrentasvir, our team at Power rated this treatment's safety as a 3. That is due to its approval for use in patients."
To what extent have Glecaprevir and Pibrentasvir been explored in other clinical studies?
"Presently, 11 clinical studies are underway to evaluate Glecaprevir and Pibrentasvir with 2 of them being in Phase 3. The majority of research sites for these two drugs is located conveniently near Baltimore, Maryland; however there are 115 other medical trial locations worldwide which investigate the safety and efficacy of Glecaprevir/Pibrentasvir."
Are there still openings in this medical experiment for participants?
"Confirmed. Clinicaltrials.gov indicates that the trial, initially posted on May 1st 2021 and updated most recently on August 2nd 2022, is presently recruiting participants. 80 patients must be enlisted from a single location."
What is the aggregate patient pool size for this clinical trial?
"Affirmative. Clinicaltrials.gov data reveals that this research initiative, which initially appeared on the 1st of May 2021, is currently recruiting participants. A total of 80 volunteers will be selected from a single site for enrollment."
What health issues can be addressed with Glecaprevir and Pibrentasvir?
"Glecaprevir and Pibrentasvir is traditionally used for those who have previously received ns5a inhibitor treatments, but can also be utilised to manage hepatitis c, chronic hepatitis c genotype 5, and chronic hepatitis c genotype 2."
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